RSV on BD Veritor™ now 510(k) Cleared and CLIA Waived
BD Diagnostics has received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA for nasopharyngeal swab specimens on the BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV). This is the first commercially available rapid CLIA-waived RSV test system that incorporates a digital result. The new assay is cleared for use in physician offices, hospitals, and other patient-care settings.
When used in conjunction with the BD Veritor System Reader, the RSV test utilizes Advanced Nano-particle and Adaptive Read technologies to obtain an accurate result while providing objective results on a hand held reader with an easy-to-read digital display. The Advanced Particle Technology along with improved chemistries helps improve the sensitivity of the test while the Adaptive Read Technology helps reduce false-positive results by examining and compensating for many of the effects of non-specific binding which improves specificity. This digital immunoassay (DIA) for Rapid Detection of RSV offers healthcare professionals a new option for RSV testing versus current visual read CLIA-waived assays.
The CLIA-waived BD Veritor System for Rapid Detection of RSV joins the previously FDA-cleared and CLIA-waived BD Veritor System for Rapid Detection of Flu A+B and Group A Strep. The BD Veritor System for Rapid Detection of RSV is the third CLIA-waived offering and BD plans to launch additional FDA-cleared assays on this platform.
Date Published: 7th April 2014
Source article link: BD Diagnostic Systems